Medical Device Risk Management (ISO 14971) & Assurance Case

The Next-Gen QMS Software Solutions

To integrate, streamline, and simplify medical product design controls, Quality by Design (QbD), risk management, cybersecurity, and safety assurance cases based on the industry best practices, and make product safety, effectiveness, time to market, cost of maintenance, compliance and quality a competitive advantage.

QMSpace™ Design Controls: All in One Solution for Design Controls

All-in-one solution for the electronic Design History File (DHF) system, fully compliant with applicable standards and regulations such as CFR 820.30, ISO 13485, Part 11, and other FDA requirements.
Out-of-the-box, best practice-based configurable templates that facilitate content creation, flow down, traceability, change impact for design input, design output, design verification, design validation, design transfer, control strategies, and risk management, as applicable.
Out-of-the-box, best practice-based configurable templates for creating and maintaining DHF (Design History File) deliverables (technical documents, plans, reports, review memos, etc.) and SOPs.
Provides a built-in editor for rich text compatible with Microsoft Word and a built-in editor for traceability tables compatible with Microsoft Excel.
Offers solutions for managing the creation, maintenance, and reuse of platforms, variants/derivatives, and library information.
Provides a configurable workflow to support team collaboration and change management at both the individual work item level and the DHF deliverable level.
Features a project management tool for tracking DHF deliverables: interdependency, schedule, status, and action items.
Provides APIs for connectivity with other electronic systems.

QMSpace™ Risk Management: All in One Global Risk Management Solution

Provides an all-in-one solution for the electronic Risk Management File (RMF) system, fully compliant with applicable standards and regulations such as ISO 14971, ISO 13485, Part 11, and other relevant FDA requirements.
Offers an all-in-one configurable solution for managing multiple types of risks (safety, cybersecurity, business, performance, etc.) and multiple risk policy sets as needed across different business units or product families.
Includes out-of-the-box, best-practice based configurable templates that facilitate content creation, traceability, and change impact for Hazard Analysis, Task Analysis, Use Error Risk Analysis, Failure Mode and Effects Analysis (dFMEA and pFMEA), and Design Controls, as applicable.
Provides built-in editors for rich text compatible with Microsoft Word and for traceability tables compatible with Microsoft Excel.
Features automatic risk value calculations and risk heat map generation based on the configurations of risk policies.
Equips users with a built-in toolkit for Fault Tree Analysis (FTA) including reliability calculations.
Delivers solutions for managing the creation, maintenance, and reuse of platforms, variants/derivatives, and library information.
Provides APIs for connectivity with other requirement management tools.

QMSpace™ Cybersecurity: All in One Global Cybersecurity Risk Management Solution

Provides an all-in-one solution for the electronic Cybersecurity Risk Management File, in compliance with standards and regulations such as AAMI TIR 57, AAMI SW96, Part 11, and FDA guidance.
Offers out-of-the-box, best-practice based configurable templates that facilitate content creation, traceability, and change impact for Asset Profiling, Threat Modeling/Attack and Vulnerability Analysis, Exploitability Assessment, SBOM, and Security Risk Summary.
Provides automatic connectivity with Safety Risk Management.
Features a configurable cybersecurity risk policy and built-in CVSS and CWSS scoring systems.
Manages the creation, maintenance, and reuse of platforms, variants/derivatives, and library information.

QMSpace™ Assurance Cases: All in One Assurance Case Development Solution

Tabular, graphic, and narrative assurance case editors
Integrates assurance case method into design controls, risk management, and cybersecurity throughout the product life cycle.
Intuitively guiding for argument development that is needed for a robust assurance case of effectiveness, safety, cybersecurity, or compliance.
Able to convert design controls, risk management, and cybersecurity information into an assurance case table or graphic.
Electronic submission of assurance cases to the FDA

Screenshots

QMspace login page

Design Input requirements

design Control Trace Matrix

System hazard anaylsis

Failure modes and effect analysis

risk assessment summary matrix